- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740644
Clinical Evaluation of the Zynex Monitoring System, Model CM-1600
February 23, 2023 updated by: Zynex Monitoring Solutions
This is a prospective, single-arm, non-randomized, non-controlled single-center study for the evaluation of the Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kristin Andrud, PhD
- Phone Number: 3457 800-495-6670
- Email: kandrud@zynex.com
Study Contact Backup
- Name: Donald Gregg
- Phone Number: 3802 800-495-6670
- Email: dgregg@zynex.com
Study Locations
-
-
Colorado
-
Louisville, Colorado, United States, 80027
- Clinimark
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant must have the ability to understand the parameters of participation and provide written informed consent
- Male or female of any race
- Participant is adult 18 or older
- Participant must be willing and able to comply with study procedures and duration
- In the Principal Investigator's medical judgment, the participant is suitable for a blood draw of up to 500mL
- Participant must weigh at least 110 pounds
Exclusion Criteria:
- Any upper extremity amputation
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Participant has a heart condition that may interfere with the Zynex CM-1600 (e.g., pacemakers, defibrillator, irregular heartbeat, dextrocardia, etc.)
- Participant has been diagnosed with chronic fatigue syndrome (also known as chronic fatigue, immune dysfunction syndrome, or myalgic encephalomyelitis)
- Participant requires equipment and/or devices that may interfere with the Zynex CM-1600 (e.g., life-sustaining equipment, other monitoring devices, insulin pumps, or other implanted devices)
- Participant is taking coumadin (warfarin), heparin, or other prescription blood thinners for 7 or more days prior to blood draw
- Participant donated blood within 8 weeks prior to the study blood draw
- Participant has high or low blood pressure on the day of blood draw (high blood pressure is defined as systolic > 180 mmHg or diastolic > 100 mmHg; low blood pressure is defined as systolic < 100 mmHg or diastolic < 60 mmHg)
- Participant has symptoms of an active infection or a temperature ≥ 100 °F
- Female with hemoglobin levels of less than 12.1g/dL or male with hemoglobin levels of less than 13.8g/dL
Participants with self-reported heart or cardiovascular conditions such as:
- History of cardiovascular surgery
- History of chest pain (angina)
- Heart rhythms other than a normal sinus rhythm or respiratory sinus arrhythmia
- History heart attack/myocardial infarction
- Peripheral arterial disease
- Carotid artery disease
- Unexplained shortness of breath
- Congestive heart failure (CHF)
- History of stroke/transient ischemic attack
- Myocardial ischemia
- Cardiomyopathy
- Dextrocardia
Participants with clotting disorders such as:
- Hemophilia
- History of blood clots
- History of bleeding problems
- Bruises easily
Self-reported health conditions as identified in the Health Assessment Form including:
- Diabetes
- Uncontrolled thyroid disease
- Kidney disease / chronic renal impairment
- History of seizures (except childhood febrile seizures)
- Epilepsy
- History of unexplained syncope
- Recent history of frequent migraine headache within the last 2 months
- Recent head injury within the last 2 months
- History of cancer, with or without chemotherapy within the last 2 months
- Other known health conditions deemed unsuitable for participation by the PI when considered upon disclosure on health assessment form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Blood Loss and Saline Infusion
|
Healthy subjects undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline will be connected to the CM-1600 device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specificity and sensitivity of minor blood loss detection and saline reinfusion
Time Frame: 24 - 36 hours
|
The objective of this study is to determine if manual blood loss of up to 500mL of blood and re-infusion of saline can be identified using the non-invasive Zynex CM-1600.
|
24 - 36 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2023
Primary Completion (Actual)
February 22, 2023
Study Completion (Actual)
February 22, 2023
Study Registration Dates
First Submitted
February 13, 2023
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Actual)
February 23, 2023
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- PR 2022-516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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